The Recall Desk

Hazard

Test Interference recalls

57 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
57
Critical
0
Severe
0
Most recent
2024-04-24

Of the 57 test interference recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all test interference recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 57

  • HighFDA (Devices)·Z-1592-2024·2024-04-24

    Fetal Membrane Rupture Test Kits Recalled for False Positive Results

    Actim PROM dipstik fetal membrane rupture test kits are recalled because personal lubricants can interfere with the test, producing false positive results.

    Product
    Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1549-2024·2024-04-24

    Siemens Atellica Lab Analyzers Risk Falsely Elevated Cholesterol Results

    Siemens Atellica CH and CI analyzers may produce falsely elevated cholesterol and lipid test results (2–16% high) after iron tests. This affects clinical calibration, quality control checks, and patient test results.

    Product
    Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN): 11537211
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2024·2024-04-10

    Abbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results

    Abbott is recalling the Alinity i Anti-HCV Reagent Kit (5110 units) due to potential false-positive test results when syphilis testing precedes the HCV test on the same instrument. Customer complaints and internal studies confirmed the interaction that may produce falsely elevated results.

    Product
    Alinity i Anti-HCV Reagent Kit, List Number 08P0521
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2023·2023-03-01

    Hepatitis B Diagnostic Test Kits Recalled for Test Interference

    Siemens is recalling ADVIA Centaur diagnostic test kits used to detect hepatitis B antibodies due to test interference that can produce false positive results when performed before another hepatitis B test on the same sample.

    Product
    ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old) and adult serum, EDTA plasma, or lithium heparin. Siemens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2022·2022-06-15

    FDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination

    Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.

    Product
    V8 Immunodisplacement Kit REF 1803
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2185-2021·2021-08-11

    Abbott Activated Alanine Aminotransferase Reagent Recalled for Inaccurate Test Results

    Abbott is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) lab reagent due to potential inaccuracies in test results. High bilirubin or high A-ALT samples may produce incorrect results affecting patient care.

    Product
    REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2875-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2020·2020-06-17

    Siemens Dimension Vista Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.

    Product
    Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2020·2020-06-17

    Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2020·2020-06-17

    Siemens ADVIA Chemistry Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2020·2020-06-17

    Siemens Atellica CH Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2281-2020·2020-06-17

    Siemens Atellica CH Fructosamine Reagent Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine Reagent because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding tw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2240-2020·2020-06-10

    Beckman Coulter Access Thyroglobulin Immunoassay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Thyroglobulin immunoassay kits because biotin supplements can cause significant test result bias.

    Product
    Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and Un
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1425-2020·2020-03-11

    Beckman Coulter Recalls Direct Bilirubin Reagents Due to Interference Risk

    Beckman Coulter is recalling Direct Bilirubin Reagents because acetaminophen metabolites may interfere with test results, potentially delaying diagnosis and treatment.

    Product
    Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1232-2020·2020-02-26

    Siemens Dimension Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagent because it may produce falsely low results for patients taking phenindione.

    Product
    Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2020·2020-02-26

    Siemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.

    Product
    Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2020·2020-02-26

    Siemens Dimension Vista Enzymatic Creatinine Reagent Recalled for Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine reagent because it may produce falsely depressed results for patients taking phenindione.

    Product
    Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1294-2019·2019-05-15

    Medica Wash1 Solution Recalled for Ineffective Probe Cleaning

    Medica Corporation is recalling Wash1 solution because it fails to clean the probe effectively, potentially causing test interference on the EasyRA analyzer.

    Product
    Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washing the probe of the Medica EasyRA Chemistry Analyzer. The wash solution in the wedge is used to prevent interference between certain tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2929-2018·2018-09-05

    Siemens RAPIDLab Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens Healthcare Diagnostics is recalling 138 RAPIDLab 1245 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tota
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2930-2018·2018-09-05

    Siemens RAPIDLab 1265 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens is recalling 2,357 RAPIDLab 1265 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including tot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2928-2018·2018-09-05

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Hydroxocobalamin Interference

    Siemens recalls RAPIDPoint 500 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2927-2018·2018-09-05

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Interference

    Siemens is recalling RAPIDPoint 405 Blood Gas Analyzers because Hydroxocobalamin may interfere with test results, potentially leading to incorrect medical assessments.

    Product
    RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolyt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2018·2018-06-13

    Tosoh Myoglobin Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2018·2018-06-13

    Tosoh ST-AIA PACK Cystatin C Assay Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cystatin C assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide